BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3153760 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06204
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: ADDR01, PACEMAKER, (B)(6) 2010; 4092-52, IMPLANTABLE PACING LEAD, (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE MAY BE PREMATURE BATTERY DEPLETION. IT WAS ALSO REPORTED PER FLUOROSCOPY ON THE DAY OF THE GENERATOR AND LEAD CHANGE THE PHYSICIAN NOTED THAT THE TIP OF THE ATRIAL LEAD HAD DROPPED DOWN TO JUST ABOVE THE ANNULUS. IN ADDITION THERE WAS INTERMITTENT CAPTURE UNIPOLAR AND BIPOLAR AT 8V/1 MSEC. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255414 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457445

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R